Patient Reported Outcome Instruments in Sarcoidosis

• Conditions: Sarcoidosis

• Registration Number: NCT04342403
• Lead Sponsor: University of Cincinnati

Brief Summary

Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Last Update Submitted: 2020-04-08
• Study First Posted: 2020-04-13
• Last Update Posted: 2020-04-13
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Diagnosis of sarcoidosis by established criteria.
• Patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit.
• Ability to understand and read English at least at a 7th grade level.
• Have access to a computer, iPad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform.
• The subject is willing to wear a daily activity and sleep tracker wristband (Fitbit ™ wristband) for 6 months.

Exclusion Criteria

• Life expectancy of < 1 year.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KSQ	6 months	Change in KSQ

Secondary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	6 months	Change in FVC percent predicted
Visual Analog Scale (VAS)	6 Months	Change in VAS
SAT	6 Months	Change in SAT

Trial Locations

Locations (3)

Albany Medical Center; 🇺🇸 Albany, New York, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States